Ash Stevens' James Hamby, R.Ph., Ph.D., Vice President of Business Development, examines the importance of communication in the Sponsor-CMO relationship. See page 18 to 19 in the digital reproduction of the magazine.

Time is of the essence in getting new drugs to market, and delays in scale-up or process development mean lost sales. So when a new anti-cancer drug was fast-tracked by the FDA, contract manufacturer Ash Stevens had to act equally fast.

Ash Stevens' emphasis on clear communication and product quality has (along with good fortune) made it a home-grown success story with an international supplier and client base. Ash Stevens President and CEO Stephen Munk shares secrets of sourcing success.

sp² profiles Ash Stevens' $6 million dollar expansion and participation and certification in SOCMA's ChemStewards program.

Ash Stevens' James Hamby, R.Ph.. Ph.D., Vice President of Business Development and Gary Baker, Ph.D, Vice President of Quality Assurance, examine common pitfalls encountered when outsourcing the development and manufacture of innovator APIs and the potential hidden benefits of outsourcing locally rather than offshore.

In this peer-reviewed case study of amines, the Hong Ming Chen, Quality Control Chemist at Ash Stevens and Laila Kott, Senior Scientist in Analytical Development, Small Molecules at Millennium Pharmaceuticals, discuss several parameters to be considered in developing a headspace GC method.

Ash Stevens' Gary A. Baker, Ph.D., Vice President of Quality Assurance and Regulatory Affairs, outlines effective cleaning procedures for CMOs.